Key information relevant to the recruitment process for the
overall study, such as dates of the recruitment period and locations

Subjects were recruited from 14 study centers in the US.

Pre-Assignment Details

Significant events and approaches for the overall study
following participant enrollment, but prior to group assignment

Of the 99 subjects enrolled, 48 were considered screen failures and were exited from the study prior to randomization. Of the 51 subjects randomized, 2 did not receive treatment. This reporting group includes all randomized subjects who received study medication.

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

This reporting group includes all randomized subjects who received study medication.

Adverse events were collected for the duration of the study. This reporting group includes all randomized subjects who received study medication.

Additional Description

An adverse event was defined as any untoward medical occurrence in a patient who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. Adverse events were obtained as solicited comments from the study patients and as observations by the Investigator as outlined in the study protocol.